Many people, as part of their daily routine, take various types of medication. Some may take several different types of pharmaceutical dosage forms in a given period. These pharmaceutical dosage forms may include pills, capsules, tablets, liquids and the like. As with many industries for which a tangible product is offered for sale, packaging is an issue. Often times, the manner in which a product is offered is a deciding factor in whether or not a purchase is made. This situation is no different in the pharmaceutical field. But other concerns may also drive the style of packaging in the pharmaceutical industry.
One packaging concern is the nature of the dosage form. Some tablets, for example, are frangible, friable or breakable (used synonymously). Such dosage forms may be easily damaged both during transport of the package and by a user upon opening. The disclosures of commonly assigned U.S. Pat. Nos. 5,178,878 and 5,223,264, which are hereby incorporated by reference herein, describe relatively soft tablets which are susceptible to this type of damage. Tablets which fall into this category tend to have a low hardness and may include very soft tablets with a hardness below about 15 Newtons.
Standard dosage forms are typically packaged in blister packages, which are comprised of multi-layered sheets of material having pockets, blisters or wells for containing the dosage forms. One type of conventional blister packages include packages having a foil layer through which a user of the package must push the tablet, thereby breaking the foil. An example of such a conventional blister package is shown in U.S. Pat. No. 4,158,411 to Hall et al, the disclosure of which is hereby incorporated by reference herein. While this type of package is sufficient for packaging standard dosage forms, packaging of frangible dosage forms in such a package would cause damage to the frangible dosage form when attempting to push it through the foil layer. These types of packages are also generally not child proof.
Another concern with the packaging of pharmaceutical dosage forms, whether they are frangible dosage forms or not, relates to safety. Child proof or child resistant packaging is often very desirable for the packaging of dosage forms. Clearly, a big concern with having medication in the home is the possibility of a child gaining access to it. On the other hand, child-proof packages may also be quite difficult to open by the elderly, handicapped or people in great pain. There needs to be a balance struck, therefore, between safety and ease of use. Packages that are more difficult for children to open than, for example, the elderly are therefore highly desirable. In addition, not all child proof packaging is the same. Packaging is often rated based on the number of children who can gain access to the drug in five minutes. One example of testing procedure standards for achieving these ratings is set forth in 16 C.F.R., and in particular §1700.00 through 1700.20 thereof.
Therefore, there exists a need for a frangible dosage package that is easy to open by the elderly or the like and child proof, while still being configured to prevent damage of the dosage that the package is designed to store.